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Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair

ConditionCleft Lip Palate
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-14
SponsorOslo University Hospital

About this trial

This prospective, randomized, double-blinded controlled trial will investigate the effectiveness of a lateral quadratus lumborum (QL) block in 50 children aged 6-14 years undergoing iliac crest bone grafting for cleft alveolus repair. Participants will receive either a lateral QL block with bupivacaine and adrenaline or a sham skin puncture.

The study will primarily assess postoperative pain at the iliac crest donor site. Secondary outcomes include pain during mobilization, pain at the alveolar surgical site, opioid consumption, time to first rescue analgesia, objective mobilization measured with activity monitors, time to hospital discharge, and adverse events.

The study aims to determine whether QL block provides clinically relevant postoperative analgesia while facilitating earlier mobilization and potentially reducing hospital stay in this pediatric population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children with cleft lip, palate and alveolus.

Scheduled for iliac crest bone grafting for cleft alveolus repair.

ASA physical status I-II.

Age from 6- 14 years old.

Disqualifiers

Allergy to local anaesthetics (e.g., bupivacaine)

Coagulation disorders or other contraindications to regional anaesthesia.

Neurological or developmental disorders that affect pain assessment or mobilization.

Skin infection at the QL injection site

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lateral quadratus lumborum block

    Procedure/Surgery

    A lateral QL blocks will be performed on the site of bone graft. An ultrasound system with a linear array transducer will be used for the QL block procedure. A sterile skin scrub will be performed before needle insertion. The ultrasound coated injection needle will be advanced until the needle tip is positioned between the aponeurosis of the transversus abdominis muscle and the pararenal fat close to the quadratus lumborum muscle. Following aspiration, 0.3 ml/kg of bupivacaine 2.5 mg/ml with adrenaline 5 mcg/ml will be injected.

  • Sham Block

    Procedure/Surgery

    Only a skin puncture will be performed

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Quadratus lumborum blockActive comparator 1 intervention
Group B: Sham treatment (skin puncture)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Pain at the Donor Site at Rest, Measured by VAS

Time frame
From 2 hours to 48 hours after the surgical procedure

Secondary outcomes

1

Postoperative pain at the donor site while standing upright, Measured by VAS

Time frame
12 hours and 24 hours after the surgical procedure
2

Postoperative Pain at the the recipient surgical site (alveolus), Measured by VAS

Time frame
From 2 hours to 48 hours after the surgical procedure
3

Time to first analgesic request, Measured in hours

Time frame
From 0 hours to 48 hours after the surgical procedure
4

Cumulative opioid consumption at 24 hours

Time frame
From 0 hours to 24 hours after the surgical intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oslo University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: